https://www.avient.com/sites/default/files/2022-12/Mevopur Healthcare Colorants and Formulations_Functional Additives for IVD Devices Bulletin.pdf
KEY CHARACTERISTICS • Manufactured at four ISO 13485 certified manufacturing sites, providing global consistency and increased security of supply • Documented change control beyond CAS number, reducing risk of change • Non-phthalate and formulated without animal-derived substances • Available as concentrates or ready-to-use formulations in a wide range of polymers • Functionality and color can be combined in one product for convenience REGULATORY SUPPORT • Raw materials tested to: - ISO 10993-1 and USP biological evaluation - European Pharmacopeia 3.1.3/3.1.5 (polyolefin) - USP (polyethylene) - ICH Q3D elemental impurities • Registered Drug Master File (Type III) and/or Device Master File • Documentation support for approval or transition to comply with (new) regulations such as IVDR APPLICATION BULLETIN Healthcare use limitations apply—see below. It is the responsibility of the medical device manufacturer and the person placing the medical device on the market to ensure compliance of the medical device with all applicable laws and regulations, including the suitability of all raw materials and components used for its manufacture.
https://www.avient.com/sites/default/files/resources/ISO9001.2015PolyOneShanghai%25282018-2021%2529.pdf
Park, Pudong, Shanghai, China, 201203 and the sites as mentioned in the appendix accompanying this certificate has been found to conform to the Quality Management System standard: ISO 9001:2015/GB/T 19001-2016 This certificate is valid for the following scope: Design and Manufacture of Masterbatch C ertificate N o: 7 071-1998-AQ-RGC-RvA P lac e and date: Shanghai, 3 0 M arch, 2 0 18 Lack of fulfilment of conditions as set out in the Certification Agreement may render this Certificate invalid. Park, Pudong, Shanghai, China, 201203 Design and Manufacture of Masterbatch Polyone - Shanghai, China (Tianjin) Branch No. 28#C , Jin Bin Hi-Tech Industrial Park, 156 Nan Hai Road, Tianjin Economic-Technological, Tianjin, China, 300457 Manufacture of Masterbatch
https://www.avient.com/sites/default/files/2020-11/glasforms-improved-adhesion-product-bulletin.pdf
Manufacturers save time and labor by eliminating the need for peel ply or other surface preparation such as grinding or abrading, while achieving superior adhesion compared to these typical processes. Pultrusions manufactured using these formulations can also enable the use of adhesives to replace mechanical fasteners, reducing complexity and improving fatigue performance. KEY CHARACTERISTICS • Improves bonding performance of epoxy adhesives in installation of pultruded parts • Eliminates need for surface preparation with abrasion or removal of peel ply layer prior to application of adhesives • Reduces overall system costs by saving time and labor on secondary processes • Enables replacement of mechanical fasteners with epoxy adhesives for improved fatigue performance and reduced weight • Simplifies manufacturing processes and reduces part complexity PRODUCT BULLETIN www.avient.com Copyright © 2020, Avient Corporation.
https://www.avient.com/sites/default/files/2024-04/Fiber-Line Composite Tape Launch Product Bulletin.pdf
Fiber-Line™ Specialty Engineered Thermoplastic Tapes PRODUCT BULLETIN Fiber-Line™ Specialty Engineered Thermoplastic Tapes are composite formulations composed of a wide range of fibers that are uniquely engineered to enhance fiber and composite tape performance— such as twisting and coating—and subsequently custom manufactured into a tape cured with a thermoplastic resin. This literature shall NOT operate as permission, recommendation, or inducement to practice any patented invention without permission of the patent owner. 1.844.4AVIENT www.avient.com Custom Manufacturing Choice of Fiber Fiber-Line™ Specialty Engineered Thermoplastic Tape Twist or Coat Fiber CUSTOM DESIGN AND ENGINEERING Combine your fiber of choice with Fiber-Line materials to enhance performance via coating or twisting processes before being formed into a thermoplastic tape. This manufacturing process enhances the thermoplastic tape’s mechanical and thermal performance for specific application needs.
https://www.avient.com/sites/default/files/2020-10/trilliant-xr-product-bulletin.pdf
X-ray and CT scanner manufacturers must design machines capable of protecting patients from harmful X-ray exposure. These machines have traditionally been manufactured using lead to provide such protection. Device manufacturers will also experience a reduction in overall exposure to this material.
https://www.avient.com/sites/default/files/2021-06/fl.us-.datasheet-petpolyester.pdf
Manufacturer FIBER-LINE® works with a variety of PET Polyester manufacturers. PET POLYESTER DATA PET POLYESTER BARE FIBER PERFORMANCE * Equilibrium moisture regain @ 55% RH ** Creep @ 40%-58% ultimate tensile strength *** Shrinkage in dry air @ 177 C for 30 minutes MOVING HIGH PERFORMANCE FIBERS FORWARD ABOUT FIBER-LINE® LOCATIONS Headquarters, R&D, Manufacturing FIBER-LINE® LLC 3050 Campus Drive Hatfield, PA 19440 +1 215.997.9181 fiber@fiber-line.com Manufacturing Operations FIBER-LINE® LLC 280 Performance Drive SE Hickory, NC 28602 +1 828.326.8700 fiber@fiber-line.com EMEA & Asia Pacific Operations FIBER-LINE® INTERNATIONAL B.V.
https://www.avient.com/sites/default/files/resources/Marine%2520Panels%2520Application%2520Bulletin.pdf
Because the manufacturing process is continuous, it also provides significant cost savings over traditional composite panel manufacturing techniques. Working together, we can help optimize your marine manufacturing system to raise throughput, increase efficiency and achieve repeatable quality.
https://www.avient.com/sites/default/files/2021-04/bergamid-seat-fastener-case-study.pdf
HellermannTyton, a global leader in designing and manufacturing fastening solutions for the automotive industry, wanted to improve upon the bent steel plate it was using to fabricate a complicated seat fastening device for a leading automotive manufacturer. The new seat securement part has already been adopted by one OEM customer, and we are confident that other manufacturers will come to us for this lightweight, cost-efficient solution.”
https://www.avient.com/sites/default/files/2021-06/fl.a4.datasheet-technora.pdf
Manufacturer Teijin™. TECHNORA® TECHNORA® DATA Standard Modulus * Equilibrium moisture regain @ 55% RH ** Creep @ 40%-58% ultimate tensile strength *** Shrinkage in dry air @ 177 C for 30 minutes MOVING HIGH PERFORMANCE FIBERS FORWARD LOCATIONS Headquarters, R&D, Manufacturing FIBER-LINE® LLC 3050 Campus Drive Hatfield, PA 19440 +1 215.997.9181 fiber@fiber-line.com Manufacturing Operations FIBER-LINE® LLC 280 Performance Drive SE Hickory, NC 28602 +1 828.326.8700 fiber@fiber-line.com EMEA & Asia Pacific Operations FIBER-LINE® INTERNATIONAL B.V.
https://www.avient.com/sites/default/files/2021-06/fl.us-.datasheet-vectranr-lcp.pdf
Manufacturer Kuraray™. LIQUID CRYSTAL POLYMER (LCP) LIQUID CRYSTAL POLYMER (HM) BARE FIBER PERFORMANCE * Equilibrium moisture regain @ 55% RH ** Creep @ 40%-58% ultimate tensile strength *** Shrinkage in dry air @ 177 C for 30 minutes MOVING HIGH PERFORMANCE FIBERS FORWARD ABOUT FIBER-LINE® LOCATIONS Headquarters, R&D, Manufacturing FIBER-LINE® LLC 3050 Campus Drive Hatfield, PA 19440 +1 215.997.9181 fiber@fiber-line.com Manufacturing Operations FIBER-LINE® LLC 280 Performance Drive SE Hickory, NC 28602 +1 828.326.8700 fiber@fiber-line.com EMEA & Asia Pacific Operations FIBER-LINE® INTERNATIONAL B.V.